Intubation, IntratrachealNCT02190032
Modified Angled Tube vs. Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation
A study testing Mallinckrodt endotracheal tube with a modified angle and Mallinckrodt endobronchial tube with a conventional angle in people with Intubation, Intratracheal and Thoracic Surgical Procedures, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intubation, Intratracheal, Thoracic Surgical Procedures
- What is being tested?
- Mallinckrodt endotracheal tube with a modified angle and Mallinckrodt endobronchial tube with a conventional angle
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing thoracic surgery under one lung ventilation
- Subjects older than 20 yrs who can give written informed consent
Who cannot join
- Those who need rapid sequence intubation
- Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)
- Those with oropharyngeal obstructive disease (including tumor, foreign body)
- Those who are expected prolonged intubation after surgery
- Those who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial
The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.
Read the detailed description
Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.
- Being tested
- Mallinckrodt endotracheal tube with a modified angle, Mallinckrodt endobronchial tube with a conventional angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mallinckrodt endotracheal tube with a modified angleDevice
Also called Tube angle modification, ("MallinckrodeTM endotracheal tube", Covidien)
At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.
Mallinckrodt endobronchial tube with a conventional angleDevice
Also called Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube
Inserting a manufacturer-provided conventional-angled tube
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien) Receives: Device: Mallinckrodt endobronchial tube with a conventional angle |
| Tube angle modification | Experimental | The angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes. Receives: Device: Mallinckrodt endotracheal tube with a modified angle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time taken to intubate a double-lumen tube
The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords
Measured: within 60 sec
Secondary outcomes (3)
The number of attempts needed for successful intubation
Measured: Intubation
The time taken for the first attempt of intubation
Measured: within 60 sec
Postoperative sore throat, hoarseness or dysphagia
Measured: 30 minutes and 24hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
- Investigators
- Jong Hwan Lee, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190032
- Sponsor's protocol ID
- 2014-06-003-004
- Status last verified
- Feb 2015
- First submitted
- 6 Jul 2014
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Min JJ, Lee JH, Kang SH, Kim E, Lee SM, Cho JH, Kim HK. The Fast and Easy Way for Double-Lumen Tube Intubation: Individual Angle-Modification. PLoS One. 2016 Aug 18;11(8):e0161434. doi: 10.1371/journal.pone.0161434. eCollection 2016.
PubMed 27537372
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02190032
- Acronym / sponsor ID
- 2014-06-003-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.
Detailed description
Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: Mallinckrodt endobronchial tube with a conventional angleIntubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien) |
| Tube angle modification | Experimental | Device: Mallinckrodt endotracheal tube with a modified angleThe angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects undergoing thoracic surgery under one lung ventilation
- Subjects older than 20 yrs who can give written informed consent
Key exclusion criteria (5 listed)
- Those who need rapid sequence intubation
- Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)
- Those with oropharyngeal obstructive disease (including tumor, foreign body)
- Those who are expected prolonged intubation after surgery
- Those who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mallinckrodt endotracheal tube with a modified angleAlso: Tube angle modification, ("MallinckrodeTM endotracheal tube", Covidien)At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes. | Device | Tube angle modification |
| Mallinckrodt endobronchial tube with a conventional angleAlso: Mallinckrodt endobronchial tube, Covidien, with conventional-angled tubeInserting a manufacturer-provided conventional-angled tube | Device | Control group |
Primary outcome
The time taken to intubate a double-lumen tube
Time frame: within 60 sec
The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords
3 secondary outcomes
The number of attempts needed for successful intubation
Time frame: Intubation
The time taken for the first attempt of intubation
Time frame: within 60 sec
Postoperative sore throat, hoarseness or dysphagia
Time frame: 30 minutes and 24hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
- Derived from this study: PubMed 27537372Min JJ, Lee JH, Kang SH, Kim E, Lee SM, Cho JH, Kim HK. The Fast and Easy Way for Double-Lumen Tube Intubation: Individual Angle-Modification. PLoS One. 2016 Aug 18;11(8):e0161434. doi: 10.1371/journal.pone.0161434. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Hwan Lee, MD,PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mallinckrodt endotracheal tube with a modified angle and Mallinckrodt endobronchial tube with a conventional angle in people with Intubation, Intratracheal and Thoracic Surgical Procedures, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time taken to intubate a double-lumen tube (time frame: within 60 sec). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190032, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.